Ischemic Reperfusion Injury
Conditions
Keywords
Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy
Brief summary
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
Detailed description
randomized controlled trial
Interventions
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient have indication for coronary angiography or angioplasty. * Impaired renal function with reduced eGFR \< 60 ml/min/1.73 m2 by CKD-EPI equation. * Written informed consent.
Exclusion criteria
* History of contrast allergy. * The patient had end-stage renal failure with the need for hemodialysis. * The patient take medications that affect the kidneys function within 48 hours before study. * The patient had acute kidney injury from any cause. * The patient was received contrast media within 2 weeks before study. * The patient had cardiac arrest or shock. * The patient had peripheral arterial disease (PAD) * Pregnancy * Refused to study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value | Within a period of 24 hours after contrast medium administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group | Within a period of 6 months after contrast medium administration | MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack |
| Incidence(%) of CI-AKI in differrent subgroups of patient characteristics | Within a period of 24 hours after contrast medium administration | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value. |
| Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost | Within a period of 24 hours after contrast medium administration | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value |
| Change in sCr and eGFR from baseline | Within a period of 24 hours after contrast medium administration | — |
| Incidence(%) of MACCE in patients with vs without RIPre and RIPost | Within a period of 6 months after contrast medium administration | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack |
| Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI | Within a period of 6 months after contrast medium administration | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration |
| Incidence(%) of MACCE in differrent subgroups of patient characteristics | Within a period of 6 months after contrast medium administration | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack |
Countries
Thailand
Contacts
Primary ContactNakarin Sansanayudh, MD,PhD
Backup ContactPawit Pipatwattanakul, MD
Outcome results
None listed